FDA Grants Priority Review to argenx’s VYVGART
argenx has announced that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics licence application (sBLA) for VYVGART in adults with acetylcholine receptor (AChR) antibody seronegative generalised myasthenia gravis (gMG).
The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of 10 May 2026, putting a clear timeline on what could become a meaningful label expansion for a patient group often left with fewer proven options.
For people living with seronegative gMG, treatment pathways can be less straightforward than for those with established antibody profiles. In argenx’s view, that gap is precisely the point.
The company’s Chief Medical Officer said patients in this group continue to face limited treatment options and that there remains a significant need to meaningfully improve their lives.
They added that the FDA’s decision to accept the sBLA with Priority Review status reflects the potential for VYVGART to address that unmet need and brings argenx closer to expanding the therapy’s use across a broader spectrum of myasthenia gravis patients.
Evidence Backing the Filing: Phase 3 ADAPT SERON
The application is supported by results from the phase 3 ADAPT SERON study, which evaluated VYVGART in adults with seronegative gMG spanning MuSK+, LRP4+, and triple seronegative subtypes.
According to the company, the trial met its primary endpoint, demonstrating a statistically significant improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared with placebo after four weeks.
Across the overall trial population, patients treated with VYVGART achieved a mean 3.35-point improvement in MG-ADL total score at week 4.
The company also reported that improvements were not limited to a single early snapshot: gains in MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were observed across subsequent treatment cycles and across all subgroups studied, reinforcing the claim that the benefit may extend across the diverse biology captured under the “seronegative” umbrella.
Safety and Tolerability: No New Signals Reported
argenx said VYVGART was well tolerated in the ADAPT SERON trial, with a safety profile described as consistent with its established use in AChR antibody seropositive gMG and other indications.
Importantly, the company noted that no new safety concerns were identified – an essential point when regulators are weighing broader use in a population that can be clinically heterogeneous.
What Happens Next
With Priority Review now in motion, argenx says it looks forward to continuing its dialogue with the FDA as the agency evaluates the application.
The PDUFA date of 10 May 2026 is the key milestone to watch, as it marks when the FDA is expected to deliver its decision on whether VYVGART’s label can formally expand to include adults with AChR antibody seronegative gMG.
Conclusion
In summary, argenx is aiming to widen access to VYVGART by moving into seronegative generalised myasthenia gravis, an area where patients can face limited treatment options.
The FDA’s Priority Review acceptance, alongside a defined PDUFA target date of 10 May 2026, signals a faster regulatory pathway.
Backed by the phase 3 ADAPT SERON study – where VYVGART delivered statistically significant improvements in MG-ADL (including a mean 3.35-point improvement at week 4) with supportive QMG findings and no new safety concerns – argenx now heads into the decisive final stretch of FDA review with the goal of reaching a broader group of people living with myasthenia gravis.
News Credits: Argenx receives review from FDA for VYVGART in seronegative gMG
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